RIGIDLOOP 232021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705022717), received between Aug 16, 2018 and Aug 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Frayed” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION, IT WAS OBSERVED THAT THE GREEN TRAILING SUTURE OF THE DEVICE BROKE. THE SURGEON SUSPECTED THAT IT MIGHT BE DAMAGED DURING GRAFT PREPARATION. THE DEVICE WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED FOR EVALUATION. NO SURGICAL DELAY OR HARM TO THE PATIENT WAS REPORTED. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7788235 ↗